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Showing posts from July, 2019

Now you see them, now you don’t: Catch those expiration date issues before your patent or exclusivity disappears!

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This blog entry is not so much about Orange Book Supplement 5 (May 2019) (see the end of this posting for that). Instead, it is a warning about the ramifications of not seeing expiration date issues, regardless of whether they were created by you or the FDA, in the Orange Book.
What brought this issue to my attention? I was making needed changes to the computer code that generates the Orange Book Archive™ (“OBA”) section of my Orange Book Companion®(“OBC”). Over the last few years, whenever the FDA made changes to its raw data files I would take the lazy route of making minor changes to the computer code which would make the new data files look like the old data files. In that way I did not have to make major changes to the downstream computer code.
For my update of the OBA to include 2018 expirations I decided to bite the bullet and make the major revisions that would allow my code to use the FDA’s current data file format directly. No more retrofitting of the new data files into the ol…